A Review on Development and Validation of Ultra Performance Liquid Chromatography for Estimation of Drug in Pharmaceutical Dosage Form
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ejpmr, 2020,7(3), 497-505 SJIF Impact Factor 6.222 EUROPEAN JOURNAL OF PHARMACEUTICAL Review Article Pradnya et al. European Journal of Pharmaceutical and Medical Research AND MEDICAL RESEARCH ISSN 2394-3211 www.ejpmr.com EJPMR A REVIEW ON DEVELOPMENT AND VALIDATION OF ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY FOR ESTIMATION OF DRUG IN PHARMACEUTICAL DOSAGE FORM. Pradnya G. Shelke*, Vijay S. Wakale and Ganesh Y. Dama Department of Quality Assurance, Sharadchandra Pawar College of Pharmacy, Dumbarwadi (Otur), Tal-Junner, Dist- Pune 412409, Maharashtra, India. *Corresponding Author: Pradnya G. Shelke Department of Quality Assurance, Sharadchandra Pawar College of Pharmacy, Dumbarwadi (Otur),Tal-Junner, Dist-Pune 412409, Maharashtra, India. Email Id: [email protected], Article Received on 21/01/2020 Article Revised on 10/02/2020 Article Accepted on 01/03/2020 ABSTRACT In recent years, remarkable technological advances have been made in particle chemistry performance, system optimization, detector design, and data processing and control. When brought together, the individual achievements in each discipline have created a step-function improvement in chromatographic performance ultra performance liquid chromatography (UPLC) is a modern technique which gives a new direction for liquid chromatography. UPLC which enhance mainly three areas of liquid chromatography: speed, resolution, and sensitivity. UPLC system column containing bridged ethylsiloxane / silica hybrid (BEH) structure with fine particle size (less than 1.7 m) is utilized and particle less than 2μm in diameter to acquire better resolution, speed, and sensitivity compared with HPLC. In twenty first centenary pharmaceutical industries are focusing for new ways to in economy and shorten time for development of drugs and drug product. The separation and quantification in UPLC is done under very high pressure (up to 100m pa). As contrast to HPLC, under high pressure it is observed that not any negative influence on analytical column and also other components like time and solvent consumption is less in UPLC. The commence review article is an endeavor to offer pervasive awareness around the development and Validation details about the UPLC and related techniques with the aim on practice to an estimation of medicinal Active agents in the last 10 years. The article also focused on general overview of UPLC. Method development and validation of UPLC method for estimation of drug and drug product. KEYWORDS: Drug, UPLC, HPLC, Resolution, 1. INTRODUCTION The Van Demeter curve governed by an equation with Analytical chemistry could be a field of study that three components shows that the usable flow range for a develops strategies, instruments and methods to get data good efficiency with small diameter particles is much on the composition and nature of matter. It is involved greater than for larger diameters The UPLC has involved with the chemical characterization of matter and the development of a new instrumental system for liquid therefore pharmaceutical analysis covers matter having chromatography, which can take advantage of the pharmaceutical applications.[1] UPLC refers to Ultra separation performance (by reducing dead volumes) and Performance Liquid Chromatography. It improves in 3 consistent with the pressures (about 8000 to 15,000 PSI, areas: activity resolution, speed and sensitivity analysis. compared with 2500 to 5000 PSI in HPLC).[5] Efficiency It uses fine particles and saves time and reduces solvent is proportional to column length and inversely consumption.[2] The UPLC relies on the principal of use proportional to the particle size18. Therefore, the column of stationary section consisting of particles but a pair of can be shortened by the same factor as the particle size μm. The underlying principles of this progress area unit without loss of resolution.[6] The application of UPLC ruled by the van Demeter equation, That is associate resulted in the detection of additional drug metabolites, formula that describes the connection between linear rate superior separation and improved spectral quality.[7] (flow rate) and plate height (HETP or column efficiency). UPLC comes from HPLC.[3] HPLC has been As particle size decreases to less than 2.5 m, there is a the evolution of the packing materials accustomed significant gain in efficiency and it’s doesn’t diminish at impact the separation.[4] increased linear velocities or flow rates according to the Van Deemter equation, common Van Deemter equation. By using smaller H = A + B/u + Cu, particles, speed and peak capacity can be expanded to new limits which is known as Ultra Performance.[8] The www.ejpmr.com 497 Pradnya et al. European Journal of Pharmaceutical and Medical Research typical separation method is of HPLC (High temperatures b) use of monolithic columns. UPLC Performance Liquid Chromatography) with many presents the possibility to extend the utility of advantages like robustness, ease of use, good selectivity conventional HPLC, a widely used separation science. and adjustable sensitivity.[9] Its main limitation is the The ACQUITY UPLC System is the first instrument of want of efficiency compared to gas chromatography or its type to include Intelligent Device Management the capillary electrophoresis due to low diffusion technology.[13,14] coefficients in liquid phase, involving slow diffusion of analytes in the stationary phase.[10] The Van Deemter SMALL PARTICLE CHEMISTRY equation shows that efficiency extent with the use of The potential of the van Deemter equation cannot be smaller size particles but this leads to a rapid increase in fulfilled without smaller particles than those consistently back pressure, while most of the HPLC system can used in HPLC.[15] The design and development of sub-2 operate only up to 378 bars.[11] That is why short mm particles is a significant challenge, and researchers columns filled with particles of about 2 m are used with have been active in this area for some time to capitalize these systems, to accelerate the analysis without loss of on their advantages. Figure 1 shows Van Deemter plot, efficiency, while maintaining an acceptable loss of showing the progress of particle sizes over the last three load.[12] To improve the efficiency of HPLC separations, decades.[16] the following can be done: - a) work at higher Fig 1: Van Deemter plot, illustrating the evolution of particle sizes over the last three decades. Although high potency, non-porous one.5 millimetre These 1.7 millimetre particles derive their increased particles area unit commercially on the market, they mechanical stability by bridging the alkyl teams within suffer from poor loading capability and retention because the silicon oxide matrix. Packing 1.7 millimetre particles of low extent. UPLC must use novel porous particles that into consistent and rugged columns was additionally a can withstand high pressures. Silica based mostly challenge that required to be overcome.[19] In addition, at particles have smart mechanical strength, but can suffer high pressures; frictional heating of the mobile phase can from a number of disadvantages, which include a limited be quite significant and must be considered. With pH range and tailing of basic analytes.[17] In 2000, a column diameters generally employed in HPLC (3.0 to primary generation hybrid chemistry that took advantage 4.6 mm), a consequence of frictional heating is the loss of the simplest of each the silicon oxide and compound of performance due to temperature induced non uniform column worlds was introduced. Producing a classical sol- flow. To minimize the effects of resistance heating, gel synthesis that includes carbon within the style of smaller diameter columns (1–2.1 mm) area unit generally alkyl teams, these columns are mechanically strong, with used for UPLC.[20,21] high efficiency, and operate over an extended pH range.[18] But, so as to supply the sort of increased ADVANTAGES OF UPLC[22,23,24] mechanical stability needed for UPLC, a second Various advantages of UPLC are as follows generation bridged ethane hybrid (BEH) technology was • Decreases run time and increases sensitivity. developed. • Less solvent consumption www.ejpmr.com 498 Pradnya et al. European Journal of Pharmaceutical and Medical Research • Provides the selectivity, sensitivity, and dynamic effects of high pressure. range of LC analysis. In addition, the phases of less than 2 m are generally • UPLC’s fast resolving power quickly quantifies non-re generable and thus have limited use. related and unrelated compounds. • Faster analysis through the use of a novel separation INSTRUMENTATION material of very fine particle size. The schematic diagramme of UPLC and various parts of the instrument are shown in Figure1, and Figure 2, • Assures end-product quality, including final release respectively. testing. • Reduces process cycle times, so that more product Parts of ultra performance liquid chromatography can be produced with existing resources. (UPLC) • Delivers real-time analysis in step with Solvent Reservoir manufacturing processes. Degasser High Pressure Pump DISADVANTAGES OF UPLC Sample Injection Port Due to increased pressure requires more Column maintenance and reduces the life of the columns of Detector these types. So far performances similar or even Data Processing and Control higher have been demonstrated by using stationary Waste phases of size around 2 m without the adverse Fig 2: Schematic diagram of UPLC. Fig. 3: UPLC instrument. Analytical RP-UPLC method development